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NCT07806240
NA

Safety and Efficacy Study of Absorbable Tacrolimus Lacrimal Canalicular Plug for Dry Eye

Sponsor: Zhejiang Raytone Bioscience Co.,Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test if a new dissolvable tacrolimus plug placed in the tear duct is safe and to see how well it works for adults with moderate to severe dry eye. The main questions it aims to answer are: Is the dissolvable tacrolimus plug safe for the eyes? How well does the plug work to improve dry eye? Participants will be divided into three groups: Two groups will receive the dissolvable tacrolimus plug inserted into their tear duct (in two slightly different sizes). One comparison group will receive an already approved dissolvable plug (Dissolvable VisiPlug). All participants will use a standard lubricating eye drop four times a day in both eyes. All participants will attend follow-up visits for 24 weeks so doctors can check their eye health and any side effects.

Official title: A Clinical New Technology Study on Evaluating the Safety and Efficacy of Absorbable Tacrolimus Lacrimal Canalicular Plug for Dry Eye Treatment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-04-08

Completion Date

2026-02-28

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DEVICE

Absorbable tacrolimus lacrimal canalicular plug

Insertion of an investigational absorbable tacrolimus lacrimal canalicular plug into the lower punctum for temporary mechanical tear duct occlusion combined with local anti-inflammatory drug delivery in moderate to severe dry eye. The plug degrades naturally over time, providing sustained release of tacrolimus to treat dry eye.

DEVICE

Dissolvable VisiPlug

Insertion of a Dissolvable VisiPlug into the lower punctum for temporary mechanical tear duct occlusion in moderate to severe dry eye.

Locations (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, China